Implantable devices and techniques for oncoplastic surgery

ABSTRACT

Described herein are devices for placement in surgically created soft tissue spaces, potential spaces, or cavities. The implantable devices generally include a bioabsorbable body having an open framework that facilitates attachment of tissue thereto in a manner that helps avoid post-surgical deformities. Methods for using the implantable devices in oncoplastic surgery are further described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 62/029,358 , filed Jul. 25, 2014, which is hereby incorporated byreference in its entirety.

FIELD

Described herein are devices for placement in surgically created softtissue spaces, potential spaces, or cavities. The implantable devicesgenerally include a bioabsorbable body having an open framework thatfacilitates attachment of tissue thereto, while supporting adjacentmargins of the surgical resection cavity in a manner that helps avoidpost-surgical deformities. Methods for using the implantable devices inoncoplastic surgery are further described.

BACKGROUND

The treatment and/or prevention of breast cancer typically includessurgery to remove an area of tissue believed or proven to be cancerousor at high risk for developing cancer over time. Various surgicalprocedures are used to remove tissue of this nature, but in general, atleast a section of the breast is removed to prevent further growth ofabnormal tissue. Such surgical procedures include removal of a portionof the breast (partial mastectomy), or if needed, the entire breast isremoved (mastectomy). Surgery is often followed by additional treatmentsto prevent recurrence of the cancer, and these treatments may includeradiation therapy and/or chemotherapy. Soon after surgery is performed,bodily fluids known as seroma fluid usually fill the surgical cavity.This fluid contains varying amounts of bloody and proteinaceousmaterials, cells that help the body during the healing process, as wellas anti-inflammatory biological elements. Seroma fluid almostimmediately fills the surgical cavity and may temporarily appear torestore the shape of the breast. However over time, the body absorbs theseroma fluid, resulting in the cavity collapsing on itself to varyingdegrees. In many cases, scar tissue develops and can cause adherence ofthe margins or walls of the cavity as a natural part of the healingprocess. This process can result in undesirable deformities of thebreast, ranging from dimpling of the overlying skin to large divots andconcavities that are unsightly and painful. In addition, radiation ofthe area compounds these effects and makes correction of these painfulabnormalities very challenging to address. When a mastectomy isperformed, inadequate amounts of skin and tissue may remain toeffectively reconstruct the breast to an acceptable aestheticappearance.

Recent advances in breast cancer treatment combine the philosophy and/orprinciples of aesthetic and reconstructive surgery (plastic surgery)with the principles and techniques of surgical oncology in an attempt torestore the form and/or function of the breast at the time of (or after)removal of abnormal tissue. This relatively new field of surgery,referred to as oncoplastic surgery, generally involves removingcancerous tissue and then manipulating and utilizing various bodytissues or rearranging the adjacent remaining tissue to help correct anydefects or gaps that were created by the surgery. In this manneradjacent tissues are used to fill the voids left in surgery, which candecrease seroma formation and improve the ultimate outcome, particularlyin regards to shape and contour of the breast. For example, tissue flapsmay be created to provide easier manipulation, approximation, rotationand closure of tissues in and around the surgical wound. There may besituations, however, when insufficient tissue is present to create theseflaps in the size needed, or to create a flap at all resulting in asmaller or malformed (deformed) breast after surgery. In otherinstances, the flap may be created in such a way that its blood supplyis compromised, ultimately causing the flap and surrounding tissues todie, leading to fat necrosis and other undesirable patient outcomes.Accordingly, it would be desirable, for example, to have a device and/ortechnique to employ in circumstances where wound tension and sparsity oftissue may otherwise cause a long-standing deformity such as followingremoval of a portion of the breast. An important goal of the devices andapproaches described herein is to improve surgical techniques for breastsurgery.

SUMMARY

Described herein are methods of breast surgery and devices for usethereof. The methods and devices may be useful in oncoplastic surgery,where it is desirable to preserve and/or improve the shape, size, andcontour of an area of the body where tissue has been surgically removed,such as the breast. In some aspects, the methods and devices providesupport for the tissue and may help to reapproximate tissues aftersurgery to prevent deformity of the skin overlying the cavity. Forexample, the methods and devices may be beneficial when insufficienttissue is present to create a tissue flap, or in the instance wheresufficient tissue is present to form a tissue flap but its creationwould compromise the blood supply to the tissue, causing tissue deathand ultimately fat necrosis.

The methods of breast surgery described herein generally include thesteps of removing tissue (such as breast tissue) to create a cavity orvoid (where the cavity or void may disrupt and/or deform the shape,size, or contour of the breast); placing an oncoplastic surgery deviceinto the cavity, where the oncoplastic device comprises a body having anopen framework formed primarily of a supportive bioabsorbable materialhaving anterior, posterior, and lateral regions; manipulating, orotherwise mobilizing, undermining, and/or rotating adjacent tissuessurrounding the cavity; and at some time during the surgical procedure,attaching the open framework to the surrounding tissue, typically viamonofilament absorbable suture. This approach eliminates the need forthe device to fill the defect, cavity or void with foreign material, asis described in, for example, U.S. Pat. No. 7,637,498 to Corbitt, Jr(“Corbitt”). In contrast to the approach described by Corbitt, theapproaches described herein include using a patient's native tissue incombination with a bioabsorbable open framework device to helpreconstruct the cosmetic deformity caused by the surgical tissueresection.

Alternatively, the methods of breast surgery may include removing anarea of breast tissue to create a cavity, an opening, or a space;placing an oncoplastic device into the cavity, the opening, or thespace, the oncoplastic device comprising a body having an open frameworkand formed of a bioabsorbable material, the open framework comprising ananterior, a posterior, and lateral regions, and an array of cross-memberelements that impart an ellipsoid profile to the open framework;manipulating tissue surrounding the cavity, the opening, or the space;and attaching the open framework to the manipulated tissue.

The oncoplastic devices described herein are implantable and may includea body formed of a bioabsorbable material. The body is generallyconfigured to have an open framework so that it can be attached totissues surrounding the cavity, e.g., by passing suture around orthrough the open framework and also through the adjacent tissue. Thebody has a length, width, and height, and may be comprised of one ormore framework elements. In some variations, the body has a geometricprofile that is generally of the form of a tri-axial ellipsoid or anoblate ellipsoid of revolution. The framework typically has sufficientrigidity to be sutured to adjacent tissue without significantlydeforming the shape of the framework element. It also may be useful forthe framework elements to have a degree of compliance, or “give” wherebythe device elements are able to move while in position to accommodatepatient movement. The compliant nature of the device framework, combinedwith the open architecture of the framework may allow the surroundingtissues to be integral within the body of the device, and may create afeeling of resilience or compliance when the area of the body overlyingthe device is touched or pressed upon through the skin, giving thedevice a natural feel to the patient. This compliance in the frameworkelements may also serve as a “strain relief” to the tissue that issutured to the device, to minimize disruption of the suture/tissueinterface. In some variations, it may be beneficial for the implantableoncoplastic devices to include a body formed of a bioabsorbable materialand having an open framework, wherein the body has a length, width, andheight, and wherein the open framework comprises a periphery and anarray of cross-member elements that impart an ellipsoid profile to theopen framework.

Additionally, the oncoplastic devices disclosed herein are generallystructured in a way that helps to support the tissue during healing,while allowing body fluids, e.g., seroma fluid, to flow freely withinthem. The seroma fluid can organize within the oncoplastic device andheal in a manner that reconstitutes the form, shape, size and or contourof the breast. This process of regrowth generally mimics the ability ofthe breast to fill in the defect as seen with autologous fat grafting.Accordingly, due to their structure, the devices generally provide ameans of autologous fat grafting without having to harvest and processfat from a remote surgical site. This in turn allows the breast to healin a more natural manner and avoid potential mammographic artifacts suchas calcifications associated with fat necrosis (unsuccessful fatgrafting). As a result of the breast tissue being able to heal in a lessstressful manner, the mammographic results may provide a more acceptablemethod for following the tumor resection area for recurrence of cancer.

The oncoplastic devices may further include a plurality of discreteradiographically visible elements, e.g., marker elements or markerclips, to aid in visualization of the device as it was placed at thesite of the surgical resection cavity and sutured to the tissues atgreatest risk for cancer recurrence. Given the specific arrangement ofthe spacing of these radiographically visible elements, they define thearea to which the radiologist or other clinicians may direct theirattention when they are seen using clinical imaging techniques such asmammography, CT, etc. Treatments after surgery often include radiation,and these visible elements of the device may be useful in a variety ofclinical circumstances, such as when focusing external radiation totarget tissue surrounding the cavity if radiation therapy issubsequently employed.

Additionally or alternatively, the framework of the oncoplastic devicemay be composed of a bioabsorbable element that has a relativelytissue-equivalent z-number that allows it to be relatively radiolucenton some types of imaging such as mammography, while marker clipcomponents coupled thereto are radiopaque and easily seen on many formsof clinical imaging (e.g., CT, MR, kV X-ray).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows one variation of an oncoplastic device comprising a single,U-shaped framework element.

FIG. 2 shows another variation of an oncoplastic device comprising asingle, circular framework element.

FIG. 3 shows another variation of an oncoplastic device comprising asingle, spiral-shaped framework element.

FIG. 4 shows another variation of an oncoplastic device comprising aplurality of framework elements.

FIG. 5 shows another variation of an oncoplastic device comprising aplurality of framework elements configured to impart compressibility tothe device.

FIG. 6 shows another variation of an oncoplastic device comprising aplurality of framework elements configured to impart compressibility tothe device.

FIG. 7 shows another variation of an oncoplastic device comprising aplurality of framework elements.

FIG. 8 shows another variation of an oncoplastic device comprising aplurality of framework elements, where one of the framework elementsconsists of a circular base and another framework element spans thediameter of the circular base.

FIGS. 9A-9D illustrate various methods by which breast tissue adjacentto the surgically created cavity can be manipulated using an exemplaryoncoplastic device.

FIG. 10 illustrates another variation of the method by which breasttissue adjacent to the surgically created cavity can be manipulatedusing other exemplary devices.

FIGS. 11-13 show perspective views of other variations of an oncoplasticdevice comprising a plurality of framework elements, where the frameworkelements include a circular base (FIG. 11), an oval base (FIGS.12A-12C), and cross-member elements of varying heights (FIG. 13).

FIG. 14 shows a CT cross sectional image of the oncoplastic device ofthe type shown in FIG. 11 in a simulated breast surgery tissueenvironment.

DETAILED DESCRIPTION

Described herein are methods of breast surgery and devices for usethereof. As previously mentioned, the methods and devices may be usefulin oncoplastic surgery, where it may be desirable to preserve and/orimprove the size, shape, and/or contour of the breast. Morespecifically, the methods and devices may facilitate the reapproximationof tissues in a manner that provides for an improved surgical outcome,which may lead to decreasing fibrosis, pain, and scar tissue formation,and may also contribute to an improved aesthetic/cosmetic outcome, aswell as mammographic outcome.

Oncoplastic Devices

The devices described herein are implantable oncoplastic surgicaldevices/tools/implants (also referred to herein as “oncoplastic devices”or “devices”) that may comprise a three-dimensional body having alength, width, and height. The body may have an open framework ortrellis-like framework that is formed from one or more frameworkelements. The devices are generally configured for open surgicalplacement into a surgical area where tissue has been removed, e.g.,lumpectomy, partial mastectomy, mastopexy, and reduction mastopexy, andemployed in a way that is useful in avoiding post-surgical deformitiesof an anatomic region.

In some variations, the device is placed and secured with suture duringthe same operation (and through the same surgical incision) as thesurgical removal of the tissue (e.g., the device is placed and securedduring the lumpectomy procedure). When placed at the original time ofsurgery, the open framework and external elements on the body of thedevice may allow for the dermal lymphatics and vasculature of the breastto heal more appropriately. However, in certain circumstances, thedevice may be used for partial breast reconstruction in patients thathave had previous breast surgery with poor cosmetic results such as aconcavity or distortion of the breast. In these circumstances, thedevice is used to fill some of the void left by removal of a givenvolume of breast tissue, as well as restore the contour and shape of thebreast. The semi-rigid, but pliable framework may allow for the deviceto “plump up” a previously depressed area of the breast, and may providea mechanism for autologous fat grafting to occur spontaneously by thebody itself without having to harvest, process and transfer fat into thearea. Scar tissue may be sutured to the framework of the device, therebydecreasing the skin tension on the overlying wound.

In some variations, the devices are secured to tissues that have beenmobilized from areas adjacent to the tissue cavity, e.g., tissue flaps.In instances where mobilization of tissue is not necessary, the devicemay be implanted with or without being secured to tissue of the cavity,and the cavity is closed around and/or through the device. The devicesdescribed herein can be used by surgeons who do not activelyreapproximate the opposing walls of a tissue cavity created by, e.g.,partial mastectomy/lumpectomy. In addition, the devices can be used bysurgeons who choose to surgically reapproximate at least a portion ofthe breast tissue surrounding the lumpectomy cavity. Thisreapproximation, sometimes called cavity closure, is typicallyaccomplished by suturing the breast tissue on either side of thelumpectomy cavity and drawing the tissue together prior to skin closure.In addition to the devices disclosed here, other suitable devices, e.g.,those structures disclosed in commonly owned U.S. application Ser. No.13/456,435 may be used with the surgical methods further describedbelow.

The framework material of the device may be relatively rigid (ornon-compressible), but the overall device can be compliant and pliableor deformable under modest loads encountered while implanted. Ingeneral, the open framework is configured to be rigid enough to supportthe surrounding tissue without fully collapsing, yet have large enoughopenings within it to allow substantial volumes of tissue to be pulledover or under it, be wrapped around it in various directions, or to flowthrough the open framework. The open architecture of the oncoplasticdevices is generally intended to maximize the opportunity for tissueingrowth, tissue mobilization, tissue approximation and/or fluidcommunication across the peripheral boundary of the device. The openarchitecture may also allow for the passage of suture around a portionof the device at multiple locations of the device by the clinician tohelp secure the device to adjacent tissue. There may also be specificsites along the device's structure intended for a more precise placementof suture or other fastening mechanisms in order to secure the device ina specific or particular manner, orientation or position.

In addition, those configurations of the device which are more linear orplanar (i.e., having a length and/or width greater than its height, andin some instances having a contoured edge to the device) may be employedto improve size, shape, and/or contour of the breast. For example, thecontoured edge can be incorporated into the tissues of the breast so asto impart a contour or projection to the reconstructed area of thebreast thereby adding contour to the skin surface of the breast forimproved cosmetic outcomes. This maneuver can be performed, for example,by placing the device in the center of the breast during a centrallumpectomy to provide additional projection. Alternatively, the devicemay be placed in an outwardly projecting orientation (perpendicular tothe skin surface), for example, underneath a vertical incision used forreduction mammoplasty. The devices may also be used with or withoutradiographically visible elements in these circumstances and can providea visual cue for the radiologist and radiation oncologist for post-optreatment or long term follow up of the surgical area.

In some variations, the body of the oncoplastic device is formed of abioabsorbable material, e.g., a bioabsorbable polymer, so as to notleave behind a permanent implant that would interfere with long termclinical imaging during patient follow-up or overall patient acceptance.Exemplary bioabsorbable polymers include without limitation, collagen,polygalactin, poliglecaprone, polylactic acid, polyglycolic acid,caprolactone, lactide, glycolide, and copolymers and blends thereof. Thebioabsorbable structure may function as a trellis, support, bridge,etc., for tissues to be sutured to, and with openings to allow tissue toflow or be pulled through it. Further, the structure may allow thetissue to heal while being supported by the underlying device, as wellas help to decrease the amount of tension on different aspects of thesurgical wound, and/or surrounding and overlying tissues such as fat,muscle, breast tissue, or skin.

The open framework of the oncoplastic devices generally comprises one ormore framework elements. The framework elements may be shaped orconstructed to at least partially conform to the contours of the tissuecavity while also preventing collapse of the cavity if desired tomaintain and/or improve the shape, size and/or contour of the specificarea of the body, such as the breast. Maintaining separation of cavitytissues is believed to be important because the adherence of tissuesduring the healing process may exacerbate the scarring process and/orlead to severe fibrotic changes causing painful and unsightlyaesthetic/cosmetic deformities as well as scar tissue that can obscurebreast tissue during post-op follow-up (e.g., mammography).

In one variation, the oncoplastic devices include a single (unitary),continuous, framework element. The single framework element may becurved, arcuate, U-shaped, spiral-shaped, undulating, circular, ovoid,flattened (sheet like) or combinations of the foregoing, etc. In anothervariation, the oncoplastic devices include a plurality of frameworkelements. The framework elements may be characterized as base elementsand spacer elements. The framework elements may take the generalgeometric profile shape of an ellipsoid or otherwise be configured toimpart an ellipsoid geometric shape to the oncoplastic device. The baseelements may take the form of a circle or an oval, to which is attachedone or more spacer elements that provide height to the device (and thusseparation of cavity tissues).

The circular and ovular base elements may have any diameter suitable forthe intended area of implantation. In some variations, the diameter ofthe circular base element may range from about 2.0 cm to about 5.0 cm.For example, the diameter of the circular base may be about 2.0 cm,about 2.5 cm, about 3.0 cm, about 3.5 cm, about 4.0 cm, about 4.5 cm, orabout 5.0 cm. There may be instances where the circular base diameter isless than 2.0 cm or more than 5.0 cm. Similarly, the diameters (shortand long diameters) of the ovular base element may range from about 2.0cm to about 6.0 cm. For example, the ovular base diameters (short andlong diameters) may be about 2.0 cm, about 2.5 cm, about 3.0 cm, about3.5 cm, about 4.0 cm, about 4.5 cm, about 5.0 cm, about 5.5 cm, or about6.0 cm. Any suitable combination of short and long diameters may beemployed for the ovular base element. It is also understood that otherframework element shapes and geometries may be used.

The length, width, and height of the oncoplastic devices may be the sameor different. In some variations, the devices are configured to have onedimension that is substantially less than the other two dimensions. Forexample, the height of the devices may be substantially less than theirwidth and length. It may be beneficial to use such low profile devicesin shallow tissue cavities or areas where there is minimal overlyingtissue, small cavities, or where there is no cavity, as in e.g.,reduction mastopexy. The height of the devices may range from about 0.2cm to about 4.0 cm. For example, the height of the device may be about0.2 cm, about 1.0 cm, about 1.5 cm, about 2.0 cm, about 2.5 cm, about3.0 cm, about 3.5 cm, or about 4.0 cm. The width and length may rangefrom about 1.0 cm to about 4.0 cm. For example, the width and length maybe about 1.0 cm, about 1.5 cm, about 2.0 cm, about 2.5 cm, about 3.0 cm,about 3.5 cm, or about 4.0 cm. In one variation, the device height isabout 1.0 cm, width is about 2.0 cm, and the length is about 3.0 cm. Itis understood that the dimensions of the device can be modified oradjusted to suit the area of intended use.

The open framework may also include a plurality of discreteradiographically visible elements spaced thereon, or therapeutic drugs,radioactive implant seeds, etc., for potential treatment of cancer or itmay contain various elements to improve or expedite tissue healingand/or prevent infection such as growth factors, vitamins, hemostaticagents, antibacterial agents, etc. These elements can be attached to theframework in a variety of ways. The elements may also be symmetricallyor asymmetrically spaced upon the framework. The discreteradiographically visible elements generally assist in delineating athree-dimensional region or volume of tissue for subsequent clinicalimaging for radiation therapy planning and delivery, and long termfollow-up. They may also provide a visual cue for the targeting andalignment of proper patient positioning during radiation treatments,e.g., serving as a fiducial marker, and provide a mechanism forclinicians to accurately target an area that may move between or duringradiation treatments. This may allow for greater accuracy in positioningfrom day to day during different sessions of radiation treatment. Thedevice is generally intended to be placed into an open surgicalresection cavity, typically at the site of tumor/cancer excision.Similarly the device allows for tracking the surgical site for thepossibility of a delayed recurrence of cancer, and having a fixedplurality of indicators allows the clinicians (e.g., the radiologistreading mammograms) to draw their attention to the exact surgical site,which is typically the most common place for recurrence to occur overtime.

FIG. 1 depicts one variation of an oncoplastic device. The oncoplasticdevice (10) has an open framework body (12) that includes a single,U-shaped framework element (14). A plurality of radiographically visibleelements (not shown) may be provided in structures (16) that are spacedupon the framework element (12). The framework element (14) may beslightly undulated so that upon placement within a tissue cavity, themarker elements may be positioned to prescribe a 3 dimensional (3D)volume. In another variation, as shown in FIG. 2, the oncoplastic device(20) includes an open framework body (22) comprising a single,continuous circular framework element (24) having a plurality ofradiographically visible elements (26) spaced thereon. In yet a furthervariation, as shown in FIG. 3, the oncoplastic device (30) includes anopen framework body (32) comprising a single, spiral-shaped frameworkelement (34). A plurality of radiographically visible elements (notshown) may be provided in structures (36) that are spaced upon theframework element (34).

FIGS. 4-8 depict variations of oncoplastic devices that include aplurality of framework elements. Referring to FIG. 4, oncoplastic device(40) has an open framework body (42) that includes a circular baseelement (44) and two curved or arcuate spacer elements (46). As shown inthe figure, the ends of the spacer elements (46) are fixed to the baseelement (44). Further, the curved or arcuate spacer elements (46) areoffset from one another in the longitudinal plane. It may be easier tomanufacture (e.g., by molding) an oncoplastic device having thisconfiguration. Again, a plurality of radiographically visible elementssuch as elements (48) may be spaced upon the framework elementseffectively at the extremities of the x, y, and z axes of the device (asshown) or along other portions of the framework elements.

FIG. 5 depicts another variation of an oncoplastic device including aplurality of framework elements. Referring to FIG. 5, oncoplastic device(50) has an open framework body (52) including an ovoid base element(54) and two curved or arcuate spacer elements (56). In this variation,one end (58) of the spacer elements (56) is not attached to the baseelement (54) to impart some compliance or compressibility to the overalldevice. A plurality of radiographically visible elements (59) (e.g.,titanium, pyrolytic carbon, gold, or other radiopaque biocompatiblesubstance) are also spaced upon and/or embedded within the frameworkelements, at desired locations as described elsewhere herein.

FIG. 6 depicts yet another variation of an oncoplastic device includinga plurality of framework elements. In FIG. 6, oncoplastic device (60)includes an open framework body (62) comprised of circular base element(64) and a single curved or arcuate spacer element (66). In thisvariation, the ends (67 a, 67 b) of the base element (64) are separated,and one end (67 b) curved outward in the direction away from theopposing spacer element (66). The end (68) of spacer element (66) andend (67 b) of base element (64) are shown as attached to other areas ofthe base element (64), but they need not be attached, e.g., if increasedcompressibility and or torsional deflection of the base element (64) isdesired. A plurality of radiographically visible elements (69) are alsospaced along the framework elements.

A further variation of an oncoplastic device comprising a plurality offramework elements is shown in FIG. 7. Referring to the figure,oncoplastic device (70) includes an open framework body (72) having anovoid base element (71) and two pairs of spacer elements (74 a and 74 b)(for a total of four) with each pair residing in orthogonal planes.Spacer elements (74 b) are attached to the other pair of spacer elements(74 a) at fixation points (76). The ends (78) of spacer elements (74 a)are attached to base element (71). A plurality of radiographicallyvisible elements (79) are also spaced along the framework elements.

Alternatively, the oncoplastic device may be configured as shown in FIG.8. In FIG. 8, oncoplastic device (80) comprises an open framework body(82) formed by a plurality of framework elements, circular base element(84) and a solid, planar, spacer element (86), which is attached to thebase element (84). It may be easier to manufacture (e.g., by molding) anoncoplastic device having this configuration. Again, a plurality ofradiographically visible elements such as elements (88) may be spacedupon the framework elements. Cutouts (89) in the solid, planar, spacerelement may also be provided to hold radiographically visible elements.

Additional variations of the oncoplastic device are provided in FIGS.11-13. Perspective views of these figures illustrate variousconfigurations of the framework elements and base elements of thedevices. FIG. 11 shows an oncoplastic device (200) that is configured toinclude a circular base element (202) with opposing cantileveredcross-member elements (framework elements, 204). The framework elements(204) function as spacer elements and are configured to impart orprovide the oncoplastic device with an overall profile (or threedimensional (3D) perimeter) in the form of an oblate ellipsoid ofrevolution. FIGS. 12A-12C show an oncoplastic device (300) that isconfigured to include an oval base element (302) with multiple (or anarray of) cantilevered cross-member elements (framework elements, 304).The profile of the framework elements (302) and (304) correspondinglyform a tri-axial ellipsoid. These cantilevered cross member elements(304) may appear straight when viewed from above (see FIG. 12B), but maybe non-straight (e.g., arcuate, “dog-legged”) in shape (e.g., whenviewed from the side) (see FIG. 12C) to provide additional height in thetransverse direction (orthogonal to the general plane of the base). Ascan be seen in FIG. 12B, the cross-member elements may or may not haveradiopaque marker elements attached to them. An important function ofthe cross-member is to prevent opposing tissue surfaces from contactingeach other during the healing process, thereby minimizing the growth ofscar tissue at that location. FIG. 13 shows another oncoplastic device(400) structured to include an oval base element (402) with multiplecantilevered cross-member elements (framework elements, 404) that impartan overall profile to the device (400) that takes the form of atri-axial ellipsoid. In this variation, the cantilevered cross-memberelements (404) are of greater height than the analogous elements of thevariation in FIGS. 12A-12C, thereby providing greater tissue separationof potential spaces or providing for the accommodation of larger tissuecavities.

FIG. 14 shows a CT cross-sectional image of the oncoplastic device ofthe type shown in FIG. 11 in a simulated breast surgery tissueenvironment. In this figure, a potential space was created in the softsimulated breast tissue via sharp dissection and then a device of thetype shown in FIG. 11 was placed in the potential space between the twoexposed dissected surfaces. As shown in the figure, the device mayprovide visualization of the tissue cavity region via the markers (500)but also note that the device holds apart the dissected tissue surfaces(502 and 504) from the opposing side of the cavity. In actualpost-surgical healing breast tissue, the device may provide a similarfunction of holding apart opposing dissected tissue surfaces, a functionwhich can minimize scarring during healing. As the physiologic healingprocess becomes less active with time post operatively, the structural(bioabsorbable) portion of the device may degrade and be absorbednaturally by the body. Reduced scarring during healing can improve thecontour of the breast and can improve visibility of the breast tissueduring follow-up mammography.

The devices described herein may be differentiated from implantableelements used for aesthetic or prosthetic reconstruction such aspermanent implants (for example, for the breast or chin) as thedisclosed devices provide a temporary structure that enables the surgeonto use the patient's own tissues to reconstruct and minimize anatomicdeformities or irregularities that would otherwise be caused by thesurgical removal of tissue. In addition, the external perimeter surfaceof these devices is generally non-contiguous as compared to a typicalprosthetic breast implant, which has a contiguous surface. Rather, thedevices disclosed herein are based upon an open framework rather than aclosed contiguous framework. The bioabsorbable nature of the implantabsorbs slowly during the healing process, but maintains its structuralintegrity while it is supporting the surrounding tissue flaps as theyheal in place and reconstitute the size, shape, form and/or contour ofthe surgical area. They may be used at the time of surgical removal, ormay be inserted into an area previously deformed by a surgicalintervention (e.g., used at a later time following excision of tissueafter a deformity has occurred due to seroma resorption and subsequentfibrotic scarring).

Furthermore, after a given period of time (e.g., after the tissuehealing response is complete), the bulk of the device is resorbed by thebody, leaving behind the tissue that has grown into or moved into theoriginal region of tissue removal, as well as leaving behind anypermanent radiographically visible elements. This attribute cancontribute to reduced scarring, minimal contour deformities, as well ascontribute to reconstruction, reconstitution of, or preservation ofprior contour, shape and size of the original anatomic region. Byproviding support to the tissues underneath the surgical wound, thedevices allow the subcutaneous tissues and in particular thesubcutaneous and/or dermal lymphatics to heal in a more efficient anddirect manner, thereby decreasing the amount of post-surgical swelling(edema), and allowing for expedited and improved healing and overallimproved aesthetic/cosmetic appearance. Also, prior to completedegradation of the bioabsorbable element(s), the radiographic elementsare held in their three-dimensional array during the tissue healingprocess, limiting their migration from their original surgically placedpositions.

As further described below, the devices may be configured to allow fortissue to be incorporated into the open framework, by way of suturing orother attachment methods (e.g., surgical clips, wires, etc.). The tissuemay be mobilized (detached) from overlying skin and surrounding tissuesin order to secure the tissue to the open framework. One way thismobilization can be achieved in breast surgery is by surgicallydissecting breast tissue along the mastectomy plane, a relativelyavascular plane of tissue that lies deep to the dermal layers to createa flap, which can then be mobilized and secured to the framework of theoncoplastic device. The tissue can be secured in many different ways tothe device, and in particular the design of the device may allow thesurgeon to customize how local reconstruction of the area isaccomplished in order to avoid anatomic irregularities. The device canbe used to reconstruct the area or otherwise improve the contour of theregion surrounding the tissue that was removed during the surgicalprocedure. Such tissues might include anything that is concerning,troublesome, suspicious for cancer, or has a known biopsy-proven cancerrequiring removal. This can be glandular tissue (e.g. breast, prostate)subcutaneous tissue (fat and fibrous tissue) and other soft tissuestructures (e.g. muscle). The devices described herein may allow thesurgeon to rearrange adjacent tissue to reconstitute and/or reconstructthe region that was excised. Accordingly, breast reconstruction forpartial mastectomy and mastopexy may be facilitated by using a temporarybioabsorbable open framework breast implant.

Methods

The methods of breast surgery described herein generally include thesteps of removing breast tissue to create a cavity, placing anoncoplastic device into the cavity, the oncoplastic device comprising abody having an open framework formed of a bioabsorbable material andhaving an anterior, posterior, and lateral regions, manipulating tissuesurrounding the cavity, and attaching (e.g., via suture) the openframework of the oncoplastic device to the manipulated tissue, asillustrated in FIGS. 9A-9D and 10. An exemplary surgically createdcavity (90) in breast tissue (92), and tissues (94) (shaded area)surrounding the cavity (90) are shown in FIG. 9A. The manipulation oftissue may comprise tissue flap creation, moving, displacing,mobilizing, or dissecting tissue (including skin) in the proximity ofthe removed tissue (including the tissue surrounding a cavity).Alternatively, the manipulation of tissue may include approximation oftissues to or within the open framework. In some instances, it is usefulat the time of surgery to perform tissue manipulation before, during, orafter placing the oncoplastic device into the cavity. In other instancesit is useful to perform tissue manipulation before, during, or aftersecuring elements (e.g., framework elements) of the open framework ofthe oncoplastic device to the tissue. In yet further instances, it maybe useful to place a cavity sizing instrument in the cavity prior toselection of the proper size of oncoplastic device and placement of theoncoplastic device.

Some variations of the method include removing an area of breast tissueto create a cavity, an opening, or a space; placing an oncoplasticdevice into the cavity, the opening, or the space, the oncoplasticdevice comprising a body having an open framework and formed of abioabsorbable material, the open framework comprising an anterior, aposterior, and lateral regions, and an array of cross-member elementsthat impart an ellipsoid profile to the open framework; manipulatingtissue surrounding the cavity, the opening, or the space; and attachingthe open framework to the manipulated tissue.

In other variations, the method may be used in a breast lumpectomyprocedure including all or some of the following steps: a lumpectomycavity is created by surgically removing breast tissue via a carefullydesigned and contoured, cosmetically chosen skin incision that may bedistinctly different from the site of the tissue removal (e.g., whichmay include tunneling from a circumareolar incision); the cavity issized using a sizer and/or other sizing methods (e.g., directexamination of the lumpectomy specimen or cavity); estimating thelocation, size, shape and orientation of the tumor; placing anappropriately sized three-dimensional open architecture bioabsorbabletissue marker (implanted) directly into the lumpectomy cavity(preferably using a device size, shape, and location that corresponds tothe size, shape, location and/or orientation of the tumor site) via thesurgical incision causing the breast tissue at the margin of the cavityto actively (e.g., via suture closure) or passively insinuate orotherwise move across the peripheral boundary of the device; closing thesurgical site via single or multiple layered closure techniques; andthen closing the skin. Creation and mobilization of tissue flaps may beperformed at any time during the above-described procedure, prior toskin closure.

Alternatively, the device may be used as above but with the added stepof passing suture around one or more portions of the device and thenpassing the suture through adjacent tissue to tether or otherwisefurther secure the device to the adjacent tissue.

In one variation, as shown in FIG. 9B, the manipulation of tissueincludes forming tissue flaps (96) by dissection beneath the skin (98)and draping the flaps (96) over an anterior region (100) of anoncoplastic device (102), in a manner somewhat analogous to an awning ortent. Although a spiral-shaped device is shown in the figure, it isunderstood that any oncoplastic device described herein may beimplanted. Cross-sectional views of the device (A) and device implantedwithin the cavity (B) are shown to provide further understanding of howthe tissues may be manipulated and attached using the device. Again,FIG. 9B depicts closure of the tissue flaps (96) over an anterior region(100) of oncoplastic device (102). This closure of tissue layers beneaththe skin, e.g., by suturing may help to prevent dimpling or divoting ofthe skin overlying the cavity, and thus preserve the natural contour ofthe breast. The oncoplastic device (102) is also secured to the tissuesurrounding the cavity at other locations desired by the surgeon, (e.g.,lateral attachment point (104)).

In other variations, the tissues can be mobilized and/or integratedwithin the device and sutured to the device at various locations throughthe device or along various aspects of its structural elements. Thetissues may be attached to the perimeter (superior, inferior, lateral,medial) regions of the device with the device being used as a “bridge”to decrease tension on an area of tissue closure. For example, as shownin FIGS. 9C and 10, tissue surrounding the cavity, e.g., tissue flaps(106, 114) can be pulled through the device (102, 116) and securedtogether.

Tissues may alternatively be connected to posterior regions of a device,as shown in FIG. 9D. Referring to the figure, device (102) is used tohelp close the posterior aspect of cavity (108). Specifically, tissues(110) that lie posterior to the device (102) are attached to a posteriorregion (112) of the device (102). In many cases a combination of theseapproaches can be used in a single patient. These are just a fewexamples of how the tissues may be secured to the device in a fashionthat envelopes tissue around, or integrates tissue within the device inorder to minimize the undesirable contour effects that the originaltissue/tumor removal would otherwise have had on the surgical area.

The methods and devices described herein generally enable surgeons tomobilize tissues into a region where they have removed tissue, and thatwould otherwise cause a void, fill with seroma fluid after surgery, andultimately create an anatomic deformity or irregularity. It facilitateslearning and practice in the field of oncoplastic surgery, which can bedescribed as combining the principles, philosophy, and techniques ofsurgical oncology (adequate tissue removal with an adequate margin),with the principles, philosophy, and techniques of aesthetic andreconstructive surgery. The ability to perform oncoplastic surgery inthis manner may be facilitated by the device because it holds thetissues in place during healing, since the tissues are secured directlyto the device. This allows the surgeon to suture the adjacent tissues(particularly after mobilization) to the device and support the tissuesduring healing, thereby preserving the contour, shape, and size of ananatomic location such as the breast. In addition, tissues may also bewrapped entirely or in part around the periphery of the device so as toenvelope the entirety or portions of the device.

The invention claimed is:
 1. A method of reconstituting the contour of abreast after surgical removal of tissue comprising: placing anoncoplastic device within a cavity or space, the cavity or space formedby the surgical removal of tissue, wherein the oncoplastic devicecomprises a body having a non-contiguous external perimeter surface, andfurther comprises a semi-rigid open framework to provide structuralsupport to the cavity or space and allow body fluids and tissue to passthrough the non-contiguous external perimeter surface and into the bodyof the device to reconstitute the contour of the breast.
 2. The methodof claim 1, further comprising manipulating the tissue surrounding theoncoplastic device.
 3. The method of claim 2, wherein manipulating thetissue surrounding the oncoplastic device comprises attaching thesurrounding tissue to the oncoplastic device.
 4. The method of claim 2,wherein manipulating the tissue surrounding the oncoplastic devicecomprises wrapping the surrounding tissue around the non-contiguousexternal perimeter surface of the oncoplastic device.
 5. The method ofclaim 4, wherein the wrapped tissue is sutured to secure it around thenon-contiguous external perimeter of the oncoplastic device.
 6. Themethod of claim 3, wherein attaching the surrounding tissue comprisessuturing the tissue to the open framework.
 7. The method of claim 1,wherein the cavity or space is formed by the surgical removal of tumortissue.
 8. The method of claim 1, wherein the open framework comprises abioabsorbable material.
 9. The method of claim 8, wherein thebioabsorbable material is mammographically radiolucent.
 10. The methodof claim 1, wherein the oncoplastic device comprises a radiographicallyvisible element.
 11. The method of claim 1, wherein the semi-rigid openframework is compliant.
 12. The method of claim 1, wherein placing theoncoplastic device into the cavity or space partially replaces a volumeof the surgically removed tissue.
 13. The method of claim 2, whereinmanipulating the tissue surrounding the oncoplastic device comprisespulling the surrounding tissue through the oncoplastic device.
 14. Themethod of claim 2 wherein manipulating the tissue surrounding theoncoplastic device comprises suturing the surrounding tissue through theopen framework.
 15. A method of reconstituting the contour of a breastcomprising: placing an oncoplastic device into a cavity or void createdby removal of a volume of breast tissue, the oncoplastic devicecomprising a body having a semi-rigid open framework to providestructural support to the cavity or void and formed of a bioabsorbablematerial, wherein the oncoplastic device is sized smaller than thecavity or void; and manipulating remaining breast tissue surrounding theoncoplastic device, wherein body fluids and tissue pass into theoncoplastic device to promote tissue regrowth within the device therebyreconstituting the contour of the breast.
 16. The method of claim 15,wherein manipulating remaining breast tissue comprises attaching tissueswithin the open framework.
 17. The method of claim 15, wherein thecavity or void has minimal overlying tissue.
 18. The method of claim 17,wherein the oncoplastic device has a flattened or low profile shape. 19.The method of claim 15, wherein the oncoplastic device is sized so thatit corresponds to the size of a tumor contained within the removedvolume of breast tissue.
 20. The method of claim 15, wherein thesemi-rigid open framework is compliant.
 21. The method of claim 15wherein the oncoplastic device comprises a radiographically visibleelement.